AneuGuide enables visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions. AneuGuide also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as:

Segmentation of neurovascular structures .
Automatic centerline detection
. Visualization of X-ray based images for 2D review and 3D reconstruction
. Placing and sizing tools
Reporting tools

Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

Device Description

The AneuGuide software is a medical device intended to provide a 3D view of the final placement of implants. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of computationally modeling the flow diverters (FD) in the artery to be treated through endovascular surgery.

AneuGuide is intended to import DICOM images and to provide a 3D reconstruction of the vascular tree in the surgical area. Also, it allows to pre-operationally estimate the size of flow diverter devices.

AneuGuide is composed of the following analysis workflows: image loading, selection of the volume of interest (VOI), segmentation threshold adjustment, reconstruction, selection of the region of interest (ROI), selection of the vessel inlet, generation of centerline, initializing the flow diverter, and sizing the flow diverter.

The flow diverter supported by the software is the Pipeline Flex Embolization Device (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, PMA: P100018/S015), which is an FDA-approved neurointerventional device. AneuGuide software has a "moderate" level of concern. It is intended only for preoperational planning. It is not intended for diagnosis.

AI/ML Overview

The ArteryFlow Technology AneuGuide software is a medical device intended for preoperational planning of neurovascular interventions, specifically for visualizing intracranial vessels and computationally modeling the placement of neurointerventional devices like flow diverters.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific quantitative thresholds. Instead, it describes general performance tests and a validation study for a key functionality: calculating the deployed length of a flow diverter. The overall acceptance criterion is implied to be that the software functions as intended, and for the flow diverter deployment, that its simulated length is sufficiently accurate compared to real-world implantation.

Acceptance Criteria Category	Specific Test/Area	Reported Performance/Outcome
Software Functionality	Importation of DICOM images	All tests passed; designed to meet requirements.
	Patient management	All tests passed; designed to meet requirements.
	Image display and processing	All tests passed; designed to meet requirements.
	Visualization of anatomic reconstruction	All tests passed; designed to meet requirements.
	Report creation and visualization	All tests passed; designed to meet requirements.
	Cybersecurity	All tests passed; designed to meet requirements.
Computational Modeling Performance	Comparison of in vitro and virtual placement of flow diverter (Pipeline Flex Embolization Device) using silicone phantoms.	These validation tests allow evaluation of the performance (error) in calculating the deployed length. (No specific numerical error reported in this summary).
	Comparison of simulated deployed length with implanted length in patients with intracranial aneurysms.	These validation tests allow evaluation of the performance (error) in calculating the deployed length. (No specific numerical error reported in this summary).

2. Sample Size and Data Provenance

Test Set Sample Size: The document mentions two performance tests for computational modeling:
- Silicone Phantoms: "Using silicone phantoms representative of patients presenting with intracranial aneurysms." The exact number of phantoms is not specified.
- Patient Implantation Data: "Validation study of the AneuGuide performance comparing the simulated deployed length of the Pipeline Flex Embolization Device with its implanted length in patients with intracranial aneurysms." The exact number of patients or cases is not specified.
Data Provenance: The document does not specify the country of origin for the patient data used in the validation study. It also does not explicitly state whether the patient data was collected retrospectively or prospectively. Given the context of comparing simulated vs. implanted lengths, it strongly implies retrospective analysis of existing patient implant data.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish the ground truth for the test set, nor does it detail their specific qualifications (e.g., radiologist with X years of experience). The general description implies that the "implanted length" from patients would serve as a real-world ground truth, presumably measured by clinical professionals.

4. Adjudication Method for the Test Set

The document does not mention any formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not explicitly done or reported. The performance tests described focus on the software's capability to accurately model physical parameters (flow diverter length) rather than evaluating human reader performance with or without AI assistance. The device is for "preoperational planning" and "not intended in any way to eliminate, replace or substitute for...the healthcare provider's judgment." This suggests it's a tool for the human, not an AI to be compared against human readers for diagnostic accuracy.

6. Standalone (Algorithm Only) Performance

Yes, the described "Performance Testing - Bench" section primarily focuses on the standalone (algorithm only) performance of AneuGuide in calculating the deployed length of the Pipeline Flex Embolization Device. The tests involved comparing the software's simulated output against physical measurements (from silicone phantoms and implanted patient data).

7. Type of Ground Truth Used

The type of ground truth used for the computational modeling performance evaluation appears to be:

Physical Measurements/Knowns: For the silicone phantom study, the "in vitro" placement is likely based on precise physical measurements of the actual flow diverter deployment in the phantoms.
Outcomes Data/Clinical Measurement: For the patient study, the "implanted length" of the flow diverter is derived from real-world patient data, presumably measured from post-implantation imaging or surgical records. This leans towards clinical outcomes/measurements as ground truth.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the AneuGuide software.

9. How Ground Truth for Training Set was Established

The document does not provide any information on how ground truth was established for the training set. Given that the software is for "computational modeling" of device placement and not explicit diagnostic AI, it's possible that the "training" (if it involved machine learning) might have used simulated data, or that "training" in this context refers more to the development and calibration of the underlying physical models rather than a typical supervised learning approach with human-labeled ground truth images.

Summary

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June 1, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

ArteryFlow Technology Co., Ltd. Jianping Xiang, Ph.D. General Manager 459 Qianmo Road, Suite C1-501, Binjiang District, 310051 Hangzhou City, Zhejiang Province, China

Re: K213838

Trade/Device Name: AneuGuide Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: PZO Dated: April 25, 2022 Received: May 2, 2022

Dear Dr. Xiang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K213838

Device Name AneuGuide

Indications for Use (Describe)

Segmentation of neurovascular structures .
Automatic centerline detection
. Visualization of X-ray based images for 2D review and 3D reconstruction
. Placing and sizing tools
Reporting tools

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K213838: 510(k) Summary

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

1. Submitter's Information

Submitter: ArteryFlow Technology Co., Ltd. Address: 459 Qianmo Road, Suite C1-501, Binjiang District, 310051 Hangzhou City, Zhejiang Province, China Phone Number: +86-571-86772567 Primary correspondent: Jianping Xiang, PhD, General Manager Email: jianping.xiang@arteryflow.com Secondary correspondent: Ashley Fu, RA Specialist Email: fang.fu@arteryflow.com Date of preparation: April 25, 2022

2. Device Information

Trade/ Device Name: AneuGuide

Common Name: Radiological Image Processing Software

Regulatory Class: Class II

Regulation Description: Medical Image Management and Processing System, Software for Visualization of Vascular Anatomy and Intravascular Devices

Regulation number: 892.2050

Classification Product Code: PZO

3. Predicate Device Information

Manufacturer: Sim&Cure Device Name: Sim&Size Regulatory Class: Class II Regulation Number: 892.2050 Classification Product Code: PZO 510(k) number: K202322

4. Device Description

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5. Intended Use / Indication for Use

General functionalities are provided such as:

Seqmentation of neurovascular structures
Automatic centerline detection
Visualization of X-ray based images for 2D review and 3D reconstruction
Placing and sizing tools
Reporting tools

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6. Comparison of Technological Characteristics

A comparison of the technological characteristics of the predicate and subject devices is provided in the table below.

Characteristic	Predicate device	Subject device
	Sim&SizeK202322	AneuGuideK213838
Indications for Use	Sim&Size enables visualization ofcerebral blood vessels for preoperationalplanning and sizing for neurovascularinterventions and surgery. Sim&Size alsoallows for the ability to computationallymodel the placement ofneurointerventional devices. Generalfunctionalities are provided such as:Segmentation of neurovascular structuresAutomatic centerline detectionVisualization of X-Ray based images for 2D review and 3D reconstructionPlacing and sizing toolsReporting toolsInformation provided by the software isnot intended in any way to eliminate,replace or substitute for, in whole or inpart, the healthcare provider's judgmentand analysis of the patient's condition.	AneuGuide enables visualization ofintracranial vessels for preoperationalplanning and sizing for neurovascularinterventions. AneuGuide also allows forthe ability to computationally model theplacement of neurointerventional devices.General functionalities are provided suchas:Segmentation of neurovascular structuresAutomatic centerline detectionVisualization of X-Ray based images for 2D review and 3D reconstructionPlacing and sizing toolsReporting toolsInformation provided by the software isnot intended in any way to eliminate,replace or substitute for, in whole or inpart, the healthcare provider's judgmentand analysis of the patient's condition.
Interface to ImageSources	DICOM Image Data	DICOM Image Data
Import of Patient Data	Manual through keyboard/mouse,automatic import with image file, studycreation list	Same
List ImageFunctionality	Deleting, anonymizing, search	Same
Image Processing	Segmentation by user with clinicianreview and comment	Same

	Table 1. General Comparison

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3D Assessment	3D assessment based on 3D model of thesimulated device inside the vessels	Same
Image and 3D Display	Orthogonal, color volume rendering, 2Dslide review, active presets, 3D view ofassemblies of devices	Same
DICOM Support	Read DICOM images from 3D rotationalangiography stations	Same
Computer OSCompatibility	MS Windows and Mac OS	Mac OS
DataInterchange/TransferMethod	Transfer by physical media, i.e. USBmemory stick and Scanner Workstations(retrieve function only)	Transfer by physical media, i.e. USBmemory stick
Output File Format	Local openGL rendering	Local VTK rendering
PreoperationalPlanning	Yes	Yes
Patient Contact	No	No
Human Interventionfor Interpretation ofImages	Yes	Yes
Implantable MedicalDevice (IMD)Database	- Pipeline™ Flex Embolization Device(Micro Therapeutics, Inc. d/b/a ev3Neurovascular, PMA numberP100018/S015)- Woven EndoBridge (WEB) AneurysmEmbolization System (MicroVention, Inc.,PMA number P170032)- Surpass Evolve Flow Diverter System(Stryker Neurovascular, P170024/S003).	- Pipeline™ Flex Embolization Device(Micro Therapeutics, Inc. d/b/a ev3Neurovascular, PMA numberP100018/S015)
Fusion correction	Automatic and manual	Manual

7. Performance Data

The following performance data were performed on AneuGuide in support of the substantial equivalence determination.

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided

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as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

The software for this device was considered as a "moderate" level of concern, since prior to mitigation of hazards, a failure of the software device could result in minor injury to a patient.

The following performance tests were conducted:

Tests of importation of DICOM images.
Patient management tests.
Tests of image display and processing.
Functioning tests for visualization of anatomic reconstruction.
Report creation and visualization tests.
Cybersecurity tests.

All tests have passed and demonstrate that the software is designed to meet the software requirements and functions as intended.

Performance Testing - Bench

The computational modeling of the Pipeline Flex Embolization Device was tested through two tests:

Using silicone phantoms representative of patients presenting with intracranial aneurysms to compare the in vitro and virtual placement of the flow diverter.
Validation study of the AneuGuide performance comparing the simulated deployed length of the Pipeline Flex Embolization Device with its implanted length in patients with intracranial aneurysms.

These validation tests allow to evaluate the performance (error) of the AneuGuide in calculating the deployed length of the Pipeline Flex Embolization Device after implantation.

8. Conclusion

The AneuGuide has the same intended use and indications for use as the predicate device Sim&Size.

Verification and validation testing have produced results consistent with design input requirements. During the development, potential hazards were controlled by the risk management report, including risk analysis, risk mitigation, verification and validation.

ArteryFlow Technology concludes that the AneuGuide, intended for preoperational planning but not for diagnosis, is as safe and effective as the predicate device. The differences between the subject and predicate devices do not raise new questions of safety and effectiveness.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).